Burns ShockNCT04928859
Study on Efficacy and Safety of Human Albumin in Burn Shock Recovery
An observational study of Burns Shock, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
To explore the effects and safety of human albumin in burn shock recovery, and then provide a theoretical basis for its rational use. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Burns Shock
- What is being tested?
- Albumin
- How many people
- 364 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2014to 30 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The patients who admitted to the burn ward of the Second Affiliated Hospital, School of Medicine, Zhejiang University and needed fluid resuscitation were identified during the period of January 2011 to December 2018.
Who may be able to join
- Age ≥ 18
- TBSA≥ 20% （TBSA，the total burn area.）
- Admitted to hospital within 24 hours after injury.
Who cannot join
- STB ≥ 33 μ mol/L
- Cr ≥ 171 μ
- Urine output l< 500 ml / 24 h
- Pregnant and lactating women
- Severe combined injury
- Glucocorticoids users
- Immunosuppressants users
- Patients survived less than 48 hours
About this study
To explore the effects and safety of human albumin in burn shock recovery, and then provide a theoretical basis for its rational use.
Read the detailed description
A retrospective case-control study was conducted. Patients who admitted to the burn ward and needed fluid resuscitation during the period of January 2011 to December 2018 in our unit were identified. Patients were divided into two groups according to the severity of burns, the patients with a 20%<TBSA≤50% constituted the moderate and severe burn group, the patients with a TBSA>50% constituted the severest burn group, and then the patients who used albumin for resuscitation constituted the albumin group, the patients who did not use albumin constituted the control group. The primary outcome was mortality, and the secondary outcomes included hospital stay, ventilator supporting, fluid use, and complications.
- Conditions
- Burns Shock
- Being tested
- Albumin
- Keywords
- burns; shock; recovery; human albumin; effect
- Medical subject headings
- Burns, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuminDrug
Also called human albumin
At least one dose of human albumin was used for the patients during hospitalization in the burn ward consisted the albumin group.
The patients who have no albumin use during their hospitalization in the burn ward consisted the control group.
| Study group | Role | What they receive |
|---|---|---|
| the albumin group | The albumin group, the patients who used albumin for resuscitation during their hospitalization in the burn ward constituted the albumin group. Receives: Drug: Albumin | |
| the control group | The control group, the patients who did not use albumin during their hospitalization in the burn ward constituted the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the mortality of the patients
The mortality of the patients during their hospitalization.
Measured: during the patients's hospitalization, an average of 1-2 month.
Secondary outcomes (4)
the length of the patients's hospital stay
the Length of the patients's hospital stay,an average of 1-2 month.
Measured: during the patients's hospitalization, an average of 1-2 month.
the number of patients that using ventilators
the number of patients who using ventilators during their hospitalization
Measured: during the patients's hospitalization, an average of 1-2 month.
Volume of fluid used for resuscitationVolume of fluid used for resuscitation the volume of the patients's resuscitation fluid
the volume of the patients's resuscitation fluid using "mL" as the measurement
Measured: during the patients's hospitalization, an average of 1-2 month.
the number of complications that the patients occurred
the number of complications that the patients occurred during their hospitalization
Measured: during the patients's hospitalization, an average of 1-2 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start1 Jun 2014
- Primary completion1 Jan 2019
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burns ShockStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hai-Bin Dai, doctor, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928859
- Sponsor's protocol ID
- 2020-489
- Status last verified
- Jun 2014
- First submitted
- 2 Jun 2021
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Efficacy and Safety of Human Albumin in Burn Shock Recovery
- ClinicalTrials.gov ID
- NCT04928859
- Acronym / sponsor ID
- 2020-489
- Conditions
- Burns Shock
- Keywords
- burns; shock; recovery; human albumin; effect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the effects and safety of human albumin in burn shock recovery, and then provide a theoretical basis for its rational use.
Detailed description
A retrospective case-control study was conducted. Patients who admitted to the burn ward and needed fluid resuscitation during the period of January 2011 to December 2018 in our unit were identified. Patients were divided into two groups according to the severity of burns, the patients with a 20%<TBSA≤50% constituted the moderate and severe burn group, the patients with a TBSA>50% constituted the severest burn group, and then the patients who used albumin for resuscitation constituted the albumin group, the patients who did not use albumin constituted the control group. The primary outcome was mortality, and the secondary outcomes included hospital stay, ventilator supporting, fluid use, and complications.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the albumin group | – | Drug: AlbuminThe albumin group, the patients who used albumin for resuscitation during their hospitalization in the burn ward constituted the albumin group. |
| the control group | – | –The control group, the patients who did not use albumin during their hospitalization in the burn ward constituted the control group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The patients who admitted to the burn ward of the Second Affiliated Hospital, School of Medicine, Zhejiang University and needed fluid resuscitation were identified during the period of January 2011 to December 2018.
Key inclusion criteria (3 listed)
- Age ≥ 18
- TBSA≥ 20% （TBSA，the total burn area.）
- Admitted to hospital within 24 hours after injury.
Key exclusion criteria (8 listed)
- STB ≥ 33 μ mol/L
- Cr ≥ 171 μ
- Urine output l< 500 ml / 24 h
- Pregnant and lactating women
- Severe combined injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlbuminAlso: human albuminAt least one dose of human albumin was used for the patients during hospitalization in the burn ward consisted the albumin group. The patients who have no albumin use during their hospitalization in the burn ward consisted the control group. | Drug | the albumin group |
Primary outcome
the mortality of the patients
Time frame: during the patients's hospitalization, an average of 1-2 month.
The mortality of the patients during their hospitalization.
4 secondary outcomes
the length of the patients's hospital stay
Time frame: during the patients's hospitalization, an average of 1-2 month.
the number of patients that using ventilators
Time frame: during the patients's hospitalization, an average of 1-2 month.
Volume of fluid used for resuscitationVolume of fluid used for resuscitation the volume of the patients's resuscitation fluid
Time frame: during the patients's hospitalization, an average of 1-2 month.
the number of complications that the patients occurred
Time frame: during the patients's hospitalization, an average of 1-2 month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hai-Bin Dai, doctor study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Burns Shock, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the mortality of the patients (time frame: during the patients's hospitalization, an average of 1-2 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.